MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ARTISTE MV SYSTEM; ACCELERATOR, LINEAR, MEDICAL

Model Number 08139789

Device Problems Fire (1245); Melted (1385); Device Emits Odor (1425); Electrical Shorting (2926); Device Contamination with Chemical or Other Material (2944); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2014

Event Type  malfunction  

Event Description

The customer informed siemens on (b)(6) 2014 of permanent equipment failure (mode intlk).The customer service engineer arrived on site and noticed a burning smell in the room and black soot was noticed on the covers.Reportedly, the linac starts by timer 7 days a week but no treatment was scheduled for that sunday.There appeared to have been a short on +24/-24v and the g41 tb1 connector melted in the process.As the gantry was parked at 270 degrees, liquid plastic flowed downward and seems to have caused a fire on the g41 head driver pcb.However, the damage was localized.There was no mistreatment or injury to a patient or facility personnel.This reported issue occurred in (b)(6).

Manufacturer Narrative

Siemens became aware of the reported issue on (b)(4) 2014.This mdr is being mailed on (b)(4) 2014.Siemens' investigation into the reported event is on-going.A supplemental report will be submitted upon completion of the investigation.Customer address: (b)(6).

• Brand Name: ARTISTE MV SYSTEM
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 757a arnold drive; martinez CA 94553
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.; 757a arnold drive.; martinez CA 94553
• Manufacturer Contact: marlynne galloway ; 51 valley stream parkway; ms-d02; malvern, PA 19355 ; 6102195361
• MDR Report Key: 3789821
• MDR Text Key: 20104078
• Report Number: 2910081-2014-02004
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K103606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08139789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2014
• Initial Date FDA Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1